1. Division of Biostatistics and Epidemiology (MLC 5041), Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA;
2. Cincinnati Children’s Hospital, Office of Research Compliance and Regulatory Affairs (MLC 7040), Cincinnati, Ohio, USA;
3. IntelliQ Health Insights, LLC, Cincinnati, Ohio, USA;
4. Academic and Regulatory Monitoring Services, LLC, Cincinnati, Ohio, USA